Unresectable pancreatic cancer
Conditions
Brief summary
Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Detailed description
Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit., Body weight change in predefined timepoints, Pain level (VAS scale), Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF, Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis
Interventions
DRUGCALCIUM CHLORATUM WZF
DRUG67 mg/ml
DRUGBleomedac 15000 IU (wg Farmakopei Europejskiej) = 15 U (wg Farmakopei Amerykańskiej)/fiolkę
Sponsors
Wroclaw Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit., Body weight change in predefined timepoints, Pain level (VAS scale), Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF, Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis | — |
Countries
Poland
Outcome results
None listed